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NCT Number: NCT07298759

The Effect of Hydroxytyrosol Administration on Superoxide Dismutase, Pulsatility Index and Resistance Index of Uterine Artery Doppler and Flow-Mediated Dilatation of Brachial Artery In Mothers With Hypertension In Pregnancy

The purpose of this clinical trial is to evaluate the effect of hydroxytyrosol 10 mg/day administered for 4 weeks in pregnant individuals with hypertension. This study will assess whether hydroxytyrosol increases serum superoxide dismutase levels, reduces uterine artery Doppler pulsatility and resistance indices, and improves brachial artery flow-mediated dilation.

Participants will be randomly assigned to receive either hydroxytyrosol or a matching placebo. Both products will be visually identical to ensure blinding. Participants will take two capsules daily for 4 weeks and attend two study visits for assessments and follow-up.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Hypertension in Pregnancy Cardiovascular Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Hypertension, Pregnancy-Induced Pregnancy Complications Urogenital Diseases Vascular Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Cipto Mangunkusumo National Central Public Hospital

Jakarta, Jakarta Special Capital Region, 10430, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Singleton pregnancy with a live intrauterine fetus
  • Gestational age 24-32 weeks. Gestational age is confirmed based on:
  • Last Menstrual Period (LMP)
  • First trimester ultrasound biometry
  • Belongs to the Hypertensive Disorders of Pregnancy group, with the following criteria:
  • Gestational hypertension and preeclampsia according to ACOG 2018 criteria
  • Chronic hypertension according to ACOG 2019 criteria
  • Superimposed preeclampsia according to ACOG 2018 criteria

Exclusion criteria

  • Pregnancy with infection, including chronic infections such as tuberculosis (TB), HIV, or hepatitis B
  • Pregnancy with other complications (e.g., diabetes mellitus, heart disease, kidney disease, liver disease, malignancy, autoimmune disorders)
  • Refusal to participate in the study

Treatment and study plan

Placebo

Dietary Supplement

Placebo oral capsule identical in appearance to hydroxytyrosol supplement, administered twice daily for 4 weeks.

Hydroxytyrosol

Dietary Supplement

Hydroxytyrosol is a natural polyphenol with antioxidant and anti-inflammatory properties, derived from olives. In this study, hydroxytyrosol 10 mg will be administered orally twice daily for 4 weeks to assess its effects on blood vessels and inflammatory biomarkers in hypertensive pregnant women.

Primary outcomes

  1. Change in superoxide dismutase (SOD) levels measured by colorimetric assay from baseline to week 4.

    Time frame: Baseline and Week 4

    To evaluate the anti-inflammatory effect of hydroxytyrosol supplementation by comparing the change in superoxide dismutase (SOD) between the hydroxytyrosol and placebo groups after 4 weeks.

    This examination utilizes blood serum as the test specimen. The reagent kit employed is the Superoxide Dismutase (SOD) Colorimetric Assay Kit (Zellbio GmbH, Germany; Cat: ZX-44108-192, Lot: ZX25003G). Measurements are conducted using a Biorad model 680 Microplate Reader (Bio-rad Laboratories Inc., CA, USA), integrated with Microplate Manager software version 5.2.1 (Bio-rad Laboratories Inc., CA, USA). The sensitivity of the device utilized in this study is 0.044 U/mL.

  2. Change in Pulsatility Index (PI) of the uterine artery Doppler from baseline to week 4.

    Time frame: Baseline and Week 4

    To evaluate the anti-inflammatory effect of hydroxytyrosol supplementation by comparing the change Pulsatility Index (PI) of the uterine artery Doppler between the hydroxytyrosol and placebo groups after 4 weeks.

    All uterine artery doppler examinations are performed using an ultrasound machine (GE Voluson E10, E8, P8, GE Medical Systems, Austria) equipped with a 2-7 MHz convex abdominal probe to obtain the uterine artery flow velocity waveforms. The insonation angle is maintained near 0 degree (<30 degrees), ensuring the peak systolic velocity are greater than 60 cm/second.

  3. Change in Resistance Index (RI) of the uterine artery Doppler from baseline to week 4.

    Time frame: Baseline and Week 4

    To evaluate the anti-inflammatory effect of hydroxytyrosol supplementation by comparing the change Resistance Index (RI) of the uterine artery Doppler between the hydroxytyrosol and placebo groups after 4 weeks.

    All uterine artery doppler examinations are performed using an ultrasound machine (GE Voluson E10, E8, P8, GE Medical Systems, Austria) equipped with a 2-7 MHz convex abdominal probe to obtain the uterine artery flow velocity waveforms. The insonation angle is maintained near 0 degree (<30 degrees), ensuring the peak systolic velocity are greater than 60 cm/second.

  4. Change in flow-mediated dilation (FMD) of brachial artery measured by an ultrasound from baseline to week 4.

    Time frame: Baseline and Week 4

    To evaluate the anti-inflammatory effect of hydroxytyrosol supplementation by comparing the change in flow-mediated dilation (FMD) of brachial artery between the hydroxytyrosol and placebo groups after 4 weeks.

    All FMD of brachial artery examinations are using a GE Voluson P6 ultrasound machine equipped with a 5-13 MHz transducer, and performed by a single operator.

Sponsors and collaborators

Lead sponsor

Dr Cipto Mangunkusumo General Hospital

Other

Registry information

Official study title

The Effect of Hydroxytyrosol Administration on Superoxide Dismutase, Pulsatility Index and Resistance Index of Uterine Artery Doppler and Flow-Mediated Dilatation of Brachial Artery In Mothers With Hypertension In Pregnancy: A Randomized Double Blind Controlled Trial

Acronym: HYDROXY-2

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Dec 23, 2025
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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